FDA 510(k)

DIBS (Digital Indirect Bonding System)

Номер K: K192701 · 2020-04-21

Дата решения2020-04-21

Код продуктаPNN

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

DIBS (Digital Indirect Bonding System) is the device name listed in this FDA 510(k) record. The listed applicant is Orthoselect, LLC. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K192701. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the DIBS (Digital Indirect Bonding System)?

DIBS (Digital Indirect Bonding System) is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Orthoselect, LLC. The 510(k) number is K192701.

When did DIBS (Digital Indirect Bonding System) receive FDA 510(k) clearance?

DIBS (Digital Indirect Bonding System) received FDA 510(k) clearance on 2020-04-21, under 510(k) number K192701.

Who is the listed applicant for DIBS (Digital Indirect Bonding System)?

The FDA 510(k) record lists Orthoselect, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIBS (Digital Indirect Bonding System)?

The FDA product code for DIBS (Digital Indirect Bonding System) is PNN.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: PNN)

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